Recent news
October 2010
FDA meets with stakeholders to discuss next steps for experimental microbicide gel
October 27, 2010 -- The US Food and Drug Administration (FDA) recently met with CONRAD and other stakeholders to discuss the next steps required for US licensure of 1% tenofovir gel, an experimental microbicide recently found to be effective at reducing the rate of HIV and herpes infection in women. During the meeting, the FDA expressed its preference for two well-controlled studies to verify the safety and efficacy of 1% tenofovir gel prior to submission of a New Drug Application (NDA). FDA officials also said that a study sponsored by the National Institutes of Health (NIH), known as VOICE, could serve as the second pivotal study, if successful, to support the submission of an NDA. In addition, the FDA has granted Fast Track approval designation for 1% tenofovir gel, which facilitates the development and expedites the review of drugs that are intended for treating serious diseases and fill an unmet medical need.
A number of stakeholders contributed to the meeting with the FDA, including representatives from the NIH, the US Agency for International Development, Gilead Sciences, the Microbicides Trial Network, South African clinical investigators, the International Partnership for Microbicides, and FHI. See the links below for more details.
- CONRAD press release
- Global Campaign for Microbicides press release
- Reuters
- Global Health Technologies Coalition feature story on recent microbicide trial
